DIABETES MELLITUS TYPE 2WALNUTNCT00901043
Effects of Walnut Consumption on Endothelial Function in Type 2 Diabetes
A study testing Walnut supplementation and Ad lib diet in people with DIABETES MELLITUS TYPE 2, run by Griffin Hospital at 1 site in United States.
Trial summary
The purpose of this study is to examine the effects of sustained walnut consumption on endothelial function and lipid markers in patients with Type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- DIABETES MELLITUS TYPE 2
- What is being tested?
- Walnut supplementation and Ad lib diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Sep 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men and women ages 35-75
- non-smoker
- able to have blood pressure taken bilaterally
- diagnosed with type 2 diabetes by physician for at least one year
- stable glucose levels and medication dose for the past 3 months
- not on insulin therapy
Who cannot join
- failure to meet inclusion criteria
- anticipated inability to complete or comply with study protocol for any reason (e.g., inability to communicate in English, dementia) or any unstable medical condition that would limit the ability of a subject to participate fully in the trial (e.g., wasting illness, AIDS, tuberculosis, psychotic disorder)
- diagnosed eating disorder
- use of lipid-lowering or antihypertensive medications (statins, red rice yeast extract, garlic) unless stable on medication for at least 3 months and willing to refrain from taking medication for 12 hours prior to endothelial function (EF) scanning, vasoactive medication (i.e., glucocorticoids, antineoplastic agents, psychoactive agents, or bronchodilators) or nutriceuticals
- regular use of multivitamins and/or complementary or alternative supplement therapy and unwillingness to discontinue supplementation for at least 8 weeks prior to study initiation and for study duration
- any rheumatologic disease requiring regular use of nonsteroidal antiinflammatory drug (NSAIDs) or alternative medications
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- regular use of fiber supplements
- preexisting cardiovascular disease, including symptomatic coronary artery disease (CAD), myocardial infarction, angina pectoris, anginal equivalent, peripheral vascular disease (claudication, amputation, or revascularization) congestive heart failure, carotid stenosis, aortic stenosis or stroke; diabetes, sleep apnea, severe uncontrolled hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 105 mmHg)
- coagulopathy, known bleeding diathesis or history of clinically significant hemorrhage; current use of warfarin
- clinically significant anemia (Hct < 36% in men, < 33% in women)
- intestinal or stomach disease
- inability to use right or left arm for endothelial function testing for any reason such as breast surgery, trauma, radiation to right axilla, lymphedema, right arm shunt, severe vascular disease in right arm
- subjects on a disease specific diet
- subjects on a weight control diet
- subjects on a vegan diet
- allergy to any kind of nut, including walnuts and peanuts
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Walnut Consumption on Endothelial Function in Type 2 Diabetes: A Randomized, Controlled, Cross-over Trial
The purpose of this study is to examine the effects of sustained walnut consumption on endothelial function and lipid markers in patients with Type 2 diabetes mellitus.
Read the detailed description
Evidence-based guidelines for the management of type 2 diabetes mellitus and related cardiovascular disease (CVD) refer to cardioprotective dietary fatty acid proportions. Several studies demonstrate the hypocholesteremic effects of walnuts in energy restricted diets. To our knowledge, the health benefits accrued as a result of addition of walnuts to an ad libitum diet in type 2 diabetic subjects have not been studied. Addition of walnuts to an ad libitum diet represents a practical way to achieve the recommended fatty acid proportions. The proposed study will examine whether a total dietary pattern inclusive of walnuts, will result in amelioration of cardiac risk as measured by improvement in endothelial function and glycemic control in type 2 diabetics. Results of the study will have important implications for clinicians and dietitians in dietary management of type 2 diabetes. Demonstrating that walnuts can be regarded as beneficial components of dietary management of type 2 diabetes is of relevance to the walnut industry as well. The study employs a pragmatic approach to approximate dietary practices in a real world setting thus enhancing the external validity of the study. If positive, the study results can inform future marketing efforts of the California Walnut Commission. Demonstrating that addition of walnuts to an ad libitum diet can potentially lead to improvement in endothelial function, improve lipid profiles, glycemic control and reduce the risk of CVD complications in diabetic patients has important applications for dietary management of diabetes.
- Conditions
- DIABETES MELLITUS TYPE 2
- Being tested
- Walnut supplementation, Ad lib diet
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walnut supplementationDietary supplement
Eight weeks of walnut supplementation
Ad lib dietDietary supplement
Eight weeks without walnut supplementation
| Study group | Role | What they receive |
|---|---|---|
| Walnut supplementation | Experimental | Eight weeks with walnut supplementation to an ad lib diet Receives: Dietary Supplement: Walnut supplementation |
| Ad lib diet | Active comparator | Eight weeks ad lib diet without walnut supplementation Receives: Dietary Supplement: Ad lib diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial artery flow mediated dilation (FMD)
Measured: 8 weeks
Secondary outcomes (1)
Change in weight, waist circumference, blood pressure, fasting lipids, fasting insulin, HBA1c and glucose levels
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2009 (estimated)
- Study startOct 2007
- Primary completionJul 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DIABETES MELLITUS TYPE 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Griffin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- California Walnut Commission
- Responsible party
- Sponsor
- Investigators
- DAVID L KATZ, MD, Principal investigator, Yale-Griffin Prevention Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901043
- Sponsor's protocol ID
- 2007-10
- Acronym
- WALNUT
- Status last verified
- Mar 2020
- First submitted
- 12 May 2009
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Walnut Consumption on Endothelial Function in Type 2 Diabetes: A Randomized, Controlled, Cross-over Trial
- ClinicalTrials.gov ID
- NCT00901043
- Acronym / sponsor ID
- WALNUT / 2007-10
- Conditions
- DIABETES MELLITUS TYPE 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Griffin HospitalUniversity, hospital or other
- Collaborators
- California Walnut Commission
- Study start
- Oct 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 13 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the effects of sustained walnut consumption on endothelial function and lipid markers in patients with Type 2 diabetes mellitus.
Detailed description
Evidence-based guidelines for the management of type 2 diabetes mellitus and related cardiovascular disease (CVD) refer to cardioprotective dietary fatty acid proportions. Several studies demonstrate the hypocholesteremic effects of walnuts in energy restricted diets. To our knowledge, the health benefits accrued as a result of addition of walnuts to an ad libitum diet in type 2 diabetic subjects have not been studied. Addition of walnuts to an ad libitum diet represents a practical way to achieve the recommended fatty acid proportions. The proposed study will examine whether a total dietary pattern inclusive of walnuts, will result in amelioration of cardiac risk as measured by improvement in endothelial function and glycemic control in type 2 diabetics. Results of the study will have important implications for clinicians and dietitians in dietary management of type 2 diabetes. Demonstrating that walnuts can be regarded as beneficial components of dietary management of type 2 diabetes is of relevance to the walnut industry as well. The study employs a pragmatic approach to approximate dietary practices in a real world setting thus enhancing the external validity of the study. If positive, the study results can inform future marketing efforts of the California Walnut Commission. Demonstrating that addition of walnuts to an ad libitum diet can potentially lead to improvement in endothelial function, improve lipid profiles, glycemic control and reduce the risk of CVD complications in diabetic patients has important applications for dietary management of diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Walnut supplementation | Experimental | Dietary Supplement: Walnut supplementationEight weeks with walnut supplementation to an ad lib diet |
| Ad lib diet | Active comparator | Dietary Supplement: Ad lib dietEight weeks ad lib diet without walnut supplementation |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- men and women ages 35-75
- non-smoker
- able to have blood pressure taken bilaterally
- diagnosed with type 2 diabetes by physician for at least one year
- stable glucose levels and medication dose for the past 3 months
Key exclusion criteria (16 listed)
- failure to meet inclusion criteria
- anticipated inability to complete or comply with study protocol for any reason (e.g., inability to communicate in English, dementia) or any unstable medical condition that would limit the ability of a subject to participate fully in the trial (e.g., wasting illness, AIDS, tuberculosis, psychotic disorder)
- diagnosed eating disorder
- use of lipid-lowering or antihypertensive medications (statins, red rice yeast extract, garlic) unless stable on medication for at least 3 months and willing to refrain from taking medication for 12 hours prior to endothelial function (EF) scanning, vasoactive medication (i.e., glucocorticoids, antineoplastic agents, psychoactive agents, or bronchodilators) or nutriceuticals
- regular use of multivitamins and/or complementary or alternative supplement therapy and unwillingness to discontinue supplementation for at least 8 weeks prior to study initiation and for study duration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walnut supplementationEight weeks of walnut supplementation | Dietary supplement | Walnut supplementation |
| Ad lib dietEight weeks without walnut supplementation | Dietary supplement | Ad lib diet |
Primary outcome
Brachial artery flow mediated dilation (FMD)
Time frame: 8 weeks
1 secondary outcome
Change in weight, waist circumference, blood pressure, fasting lipids, fasting insulin, HBA1c and glucose levels
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DAVID L KATZ, MD principal investigator
Yale-Griffin Prevention Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walnut supplementation and Ad lib diet in people with DIABETES MELLITUS TYPE 2, run by Griffin Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brachial artery flow mediated dilation (FMD) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020; AzTrials last refreshed its copy on 30 Oct 2026.